FDA.reportPublic FDA data

Sodium fluoride

Product NDC
65517-2000
Requested package NDC
65517-2000-4
11-digit product format
655172000
Labeler code
65517
Product ID
65517-2000_1cbd9395-3d74-b411-e063-6394a90afb29
Type
HUMAN OTC DRUG
Nonproprietary name
Toothpaste
Dosage form
CREAM
Route
ORAL
Labeler
DUKAL LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-13
Marketing end
2026-07-31
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65517-200065517-2000-4DDiscontinued by firm2026-08-11

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
65517-2000-0DAWNMIST TOOTHPASTE
65517-2000-1DAWNMIST TOOTHPASTE
65517-2000-2DAWNMIST TOOTHPASTE
65517-2000-3DAWNMIST TOOTHPASTE
65517-2000-4DAWNMIST TOOTHPASTE
65517-2000-5DAWNMIST TOOTHPASTE
65517-2000-6DAWNMIST TOOTHPASTE
65517-2000-7DAWNMIST TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2000-0Sodium fluoride17 g in 1 TUBECREAM176
65517-2000-1Sodium fluoride24 g in 1 TUBECREAM246
65517-2000-2Sodium fluoride42 g in 1 TUBECREAM426
65517-2000-3Sodium fluoride78 g in 1 TUBECREAM786
65517-2000-4Sodium fluoride1 in 1 BOXCREAM16
65517-2000-4Sodium fluoride42 g in 1 TUBECREAM426
65517-2000-5Sodium fluoride78 g in 1 TUBECREAM786
65517-2000-5Sodium fluoride1 in 1 BOXCREAM16
65517-2000-6Sodium fluoride135 g in 1 TUBECREAM1356
65517-2000-6Sodium fluoride1 in 1 BOXCREAM16
65517-2000-7Sodium fluoride181 g in 1 TUBECREAM1816
65517-2000-7Sodium fluoride1 in 1 BOXCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
POTASSIUM NITRATEINACTIVE INGREDIENTRU45X2JN0ZSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SORBITOLINACTIVE INGREDIENT506T60A25RSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2000SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL LLC]6Current NDC, Legacy NDC, 12 package rows20240709_460c0f54-367a-4300-b066-5071d718ea73.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
Made by Dentists Enamel 10 Fluoride AnticavityPOTASSIUM NITRATE, SODIUM FLUORIDEMade By Dentists Inc3c62eab1-0cb6-4bdf-bfd4-c5afe734d0362026-07-24WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-07-06WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-07-03WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN460c0f54-367a-4300-b066-5071d718ea736
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD460c0f54-367a-4300-b066-5071d718ea736
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY460c0f54-367a-4300-b066-5071d718ea736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-2000-4655172000041 TUBE in 1 BOX (65517-2000-4) / 42 g in 1 TUBE1 tube2015-02-192026-07-31NoNoCurrent